FDA · Class II · September 23, 2026

Well Lead Medical recall: SunMed Tracheal Tube

Well Lead Medical Co. LTD is recalling SunMed Tracheal Tube – 27200. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 31, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductSunMed Tracheal Tube
BrandWell Lead Medical
CompanyWell Lead Medical Co. LTD
TypeMedical devices
ClassificationClass II
Recall dateJuly 31, 2026
Published by FDASeptember 23, 2026
Quantity27200
Recall ID99685
As listed by FDA

Recalled products

  1. SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
    FDA recall number
    Z-3172-2026
    Codes, lots and dates
    Model Number: 1-7333-25; UDI-DI:10889483048108; Lot No.: 2108011462, 2108011506, 2109011963, 2111012039, 2112012040, 2204010568, 2204010569, 2204010734, 2205010833, 2207011263, 2208011729, 2208011789, 2304010830, 2306011372, 2306011425, 2308011907, 2308012011, 2308012012, 2309012128, 2310012358, 2310012599, 2311013016, 2311012924, 2312013223, 2401010069, 2401010197, 2402010378, 2403010466, 2403010889, 2404010999, 2406011822, 2407012282, 2408012389, 2409012800, 2409012882, 2508013006, 2510013653, 2511014081, 2512014080, 2602010272, 2603010274, 2603010900, 2604011014, 2604011416, 2605011923, 2605011924;
    Quantity
    27200
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99685
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Guangzhou, N/A, China

Why it was recalled

The reason the FDA lists: “The 6Fr suction catheter could not pass through the samples smoothly.”

Where it was sold

Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the state of MI.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99685, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Well Lead Medical SunMed Tracheal Tube recalled?

Yes. Well Lead Medical Co. LTD recalled it on July 31, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

The 6Fr suction catheter could not pass through the samples smoothly.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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